Study on T-Cell Changes After Radiation Therapy Alone and with M9241 in Prostate Cancer Treated with Hormone Therapy

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05361798

This clinical trial is exploring whether adding a new drug, M9241, to standard radiation and hormone therapy can help the immune system fight prostate cancer more effectively. The study aims to find safe doses of M9241 and understand its effects on the immune system in patients with localized high- and intermediate-risk prostate cancer.

Patient Parameters

Program Overview

Prostate cancer is often treated with radiation and hormone therapy, but up to 30% of these cancers can return within 5 years. This study is testing a new drug, M9241, to see if it can help the immune system fight prostate cancer better. The main goal is to find safe doses of M9241 and see how it affects the immune system. Participants will be adults with high- or intermediate-risk prostate cancer that hasn't spread. The study will last 7 months and includes screening, treatment, and follow-up visits.

Description

This study is investigating whether a new drug, M9241, can enhance the effects of radiation therapy and hormone therapy in treating prostate cancer. Prostate cancer patients often receive radiation and hormone therapy, but many still experience a return of cancer. M9241 is designed to boost the immune system's ability to fight cancer. The study will test different doses of M9241 to find the safest and most effective amount. Participants will receive standard radiation and hormone therapy, and some will also receive M9241 injections. The study will monitor the immune system's response to these treatments. Participants will undergo various tests, including blood tests, scans, and biopsies, to track their progress. The study aims to improve treatment outcomes for prostate cancer patients by enhancing the body's natural defenses against cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed localized intermediate or high-risk prostate cancer:
    • Intermediate risk: Gleason score of 7, PSA less than 10
    • High risk: Gleason score 8-10, PSA greater than 10, or cancer spread beyond the prostate capsule
  • Must need radiation therapy and hormone therapy
  • Must provide a tissue sample for analysis
  • Male, aged 18 years or older
  • Good overall health with specific blood and organ function levels
  • Must agree to use contraception during and after the study
  • Must have prostate cancer that can be biopsied
  • Must understand and agree to the study requirements

Exclusion Criteria

  • Cancer has spread beyond the pelvis
  • Previous prostate surgery or radiation
  • Started hormone or radiation therapy before joining the study
  • Recent live vaccines (except flu and COVID vaccines)
  • Allergies to MRI contrast agents
  • Conditions that prevent safe radiation therapy
  • Health issues that prevent hormone therapy
  • Active immune system disorders or on immunosuppressive drugs
  • HIV positive
  • Active Hepatitis B or C
  • Serious infections like tuberculosis
  • Allergies to similar drugs as M9241
  • Other active cancers within the last 3 years, except certain skin or low-risk prostate cancers

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